JPWO2020100080A5 - - Google Patents
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- JPWO2020100080A5 JPWO2020100080A5 JP2021526255A JP2021526255A JPWO2020100080A5 JP WO2020100080 A5 JPWO2020100080 A5 JP WO2020100080A5 JP 2021526255 A JP2021526255 A JP 2021526255A JP 2021526255 A JP2021526255 A JP 2021526255A JP WO2020100080 A5 JPWO2020100080 A5 JP WO2020100080A5
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- cerepressin
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- 239000000203 mixture Substances 0.000 claims description 36
- MYMOFIZGZYHOMD-UHFFFAOYSA-N oxygen Chemical compound O=O MYMOFIZGZYHOMD-UHFFFAOYSA-N 0.000 claims description 20
- 229910052760 oxygen Inorganic materials 0.000 claims description 20
- 239000001301 oxygen Substances 0.000 claims description 20
- 210000002966 Serum Anatomy 0.000 claims description 9
- JVTAAEKCZFNVCJ-UHFFFAOYSA-M lactate Chemical compound CC(O)C([O-])=O JVTAAEKCZFNVCJ-UHFFFAOYSA-M 0.000 claims description 9
- 239000005526 vasoconstrictor agent Substances 0.000 claims description 9
- 230000000033 vasopressor Effects 0.000 claims description 9
- 238000001802 infusion Methods 0.000 claims description 7
- 206010040070 Septic shock Diseases 0.000 claims description 6
- 238000001990 intravenous administration Methods 0.000 claims description 6
- 230000036303 septic shock Effects 0.000 claims description 6
- 238000002560 therapeutic procedure Methods 0.000 claims description 6
- 230000001419 dependent Effects 0.000 claims description 3
- 239000000496 cardiotonic agent Substances 0.000 claims description 2
- 239000005555 hypertensive agent Substances 0.000 claims description 2
- 230000000977 initiatory Effects 0.000 claims description 2
- SFLSHLFXELFNJZ-QMMMGPOBSA-N (-)-norepinephrine Chemical compound NC[C@H](O)C1=CC=C(O)C(O)=C1 SFLSHLFXELFNJZ-QMMMGPOBSA-N 0.000 description 2
- SFLSHLFXELFNJZ-MRVPVSSYSA-N L-Noradrenaline Natural products NC[C@@H](O)C1=CC=C(O)C(O)=C1 SFLSHLFXELFNJZ-MRVPVSSYSA-N 0.000 description 2
- 229960002748 Norepinephrine Drugs 0.000 description 2
- JCVQBJTWWDYUFQ-MRUTUVJXSA-N Selepressin Chemical compound C([C@H]1C(=O)N[C@H](C(N[C@@H](CCCC(N)=O)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CSSC[C@H](N)C(=O)N1)C(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CCCNC(C)C)C(=O)NCC(N)=O)=O)[C@@H](C)CC)C1=CC=CC=C1 JCVQBJTWWDYUFQ-MRUTUVJXSA-N 0.000 description 1
- 229950008103 Selepressin Drugs 0.000 description 1
- 230000003044 adaptive Effects 0.000 description 1
- 239000000556 agonist Substances 0.000 description 1
- KBZOIRJILGZLEJ-LGYYRGKSSA-N argipressin Chemical compound C([C@H]1C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CSSC[C@@H](C(N[C@@H](CC=2C=CC(O)=CC=2)C(=O)N1)=O)N)C(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CCCN=C(N)N)C(=O)NCC(N)=O)C1=CC=CC=C1 KBZOIRJILGZLEJ-LGYYRGKSSA-N 0.000 description 1
- 229940068196 placebo Drugs 0.000 description 1
- 239000000902 placebo Substances 0.000 description 1
- 239000000758 substrate Substances 0.000 description 1
- 229960003726 vasopressin Drugs 0.000 description 1
Description
次に、本発明のまた別の好ましい態様を示す。
１． 昇圧剤療法を必要とする患者における敗血症の治療に使用されるセレプレッシンを含む組成物であって、前記患者が前記昇圧剤療法を必要とする時から６時間以内に前記患者に投与される、セレプレッシンを含む組成物。
２． 前記患者が、治療前に約２００を超える動脈血酸素分圧対吸入酸素濃度の比（ＰａＯ 2 ／ＦｉＯ 2 ）を有する、又は有すると同定される、上記１に記載の使用されるセレプレッシンを含む組成物。
３． 前記患者が、治療前に約２ｍｍｏｌ／Ｌ未満の血清乳酸濃度を有する、又は有すると同定される、上記１又は２に記載の使用されるセレプレッシンを含む組成物。
４． 患者における敗血症の治療に使用されるセレプレッシンを含む組成物であって、前記患者が、治療前に２ｍｍｏｌ／Ｌ未満の血清乳酸濃度を有する、組成物。
５． 前記患者が、治療前に約２ｍｍｏｌ／Ｌ未満の血清乳酸濃度を有すると同定される、上記４に記載の使用される組成物。
６． 患者における敗血症の治療に使用されるセレプレッシンを含む組成物であって、前記患者が、治療前に約２６０を超える動脈血酸素分圧対吸入酸素濃度の比（ＰａＯ 2 ／ＦｉＯ 2 ）を有する、組成物。
７． 前記患者が、治療前に約２６０を超える動脈血酸素分圧対吸入酸素濃度の比（ＰａＯ 2 ／ＦｉＯ 2 ）を有すると同定される、上記６に記載の使用される組成物。
８． 前記動脈血酸素分圧対吸入酸素濃度の比（ＰａＯ 2 ／ＦｉＯ 2 ）が治療前に約３００を超える、上記６又は７に記載の使用されるセレプレッシンを含む組成物。
９． 前記敗血症が昇圧剤依存性敗血症である、上記１から８のいずれか一項に記載の使用されるセレプレッシンを含む組成物。
１０． 前記敗血症が敗血症性ショックである、上記１、２、６、７又は８のいずれか一項に記載の使用されるセレプレッシンを含む組成物。
１１． 昇圧剤療法を必要とする患者において敗血症を治療する方法であって、前記患者が前記昇圧剤療法を必要とする時から６時間以内に、前記患者にセレプレッシンを含む組成物を投与することを含む、方法。
１２． 前記患者が、治療前に約２ｍｍｏｌ／Ｌ未満の血清乳酸濃度を有する、又は有すると同定される、上記１１に記載の方法。
１３． 前記患者が、治療前に約２００を超える動脈血酸素分圧対吸入酸素濃度の比（ＰａＯ 2 ／ＦｉＯ 2 ）を有する、又は有すると同定される、上記１１又は１２のいずれか一項に記載の方法。
１４． セレプレッシンを含む組成物を、その必要がある患者に投与することを含む敗血症を治療する方法であって、前記患者が治療前に２ｍｍｏｌ／Ｌ未満の血清乳酸濃度を有する、方法。
１５． 前記患者が治療前に約２ｍｍｏｌ／Ｌ未満の血清乳酸濃度を有すると同定される、上記１４に記載の方法。
１６． セレプレッシンを含む組成物を、その必要がある患者に投与することを含む、敗血症を治療する方法であって、前記患者が、治療前に約２６０を超える動脈血酸素分圧対吸入酸素濃度の比（ＰａＯ 2 ／ＦｉＯ 2 ）を有する、方法。
１７． 前記患者が、治療前に約２６０を超える動脈血酸素分圧対吸入酸素濃度の比（ＰａＯ 2 ／ＦｉＯ 2 ）を有すると同定される、上記１６に記載の方法。
１８． 前記動脈血酸素分圧対吸入酸素濃度の比（ＰａＯ 2 ／ＦｉＯ 2 ）が治療前に約３００を超える、上記１６又は１７に記載の方法。
１９． 前記敗血症が昇圧剤依存性敗血症である、上記１１から１８のいずれか一項に記載の方法。
２０． 前記敗血症が敗血症性ショックである、上記１１、１３、１６、１７又は１８のいずれか一項に記載の方法。
２１． 前記セレプレッシンが、静脈内又は皮下投与される、上記１１から２０のいずれか一項に記載の使用又は方法のためのセレプレッシンを含む組成物。
２２． 前記セレプレッシンが、投与速度約１．７ｎｇ／ｋｇ／分～約７．５ｎｇ／ｋｇ／分にて静脈内持続注入によって投与される、上記１１から２０のいずれか一項に記載の使用又は方法のためのセレプレッシンを含む組成物。
２３． 前記セレプレッシンが、静脈内輸液投与開始速度約１．７ｎｇ／ｋｇ／分～約５．０ｎｇ／ｋｇ／分；且つ静脈内輸液投与最大速度約２．５ｎｇ／ｋｇ／分～約７．５ｎｇ／ｋｇ／分にて静脈内持続注入によって投与される、上記２２に記載の使用又は方法のためのセレプレッシンを含む組成物。
２４． 前記セレプレッシンが、更なる抗低血圧薬と共に投与される、上記１１から２０のいずれか一項に記載の使用又は方法のためのセレプレッシンを含む組成物。
２５． 前記セレプレッシンが、強心薬と共に投与される、上記１１から２０のいずれか一項に記載の使用又は方法のためのセレプレッシンを含む組成物。
参考文献
１．Ｒｕｓｓｅｌｌ， Ｊａｍｅｓ Ａ．ｅｔ ａｌ．，Ｖ１Ａ ａｇｏｎｉｓｔ ｉｓ ａｎ ｅｆｆｅｃｔｉｖｅ ｓｕｂｓｔｉｔｕｔｅ ｆｏｒ ｎｏｒｅｐｉｎｅｐｈｒｉｎｅ ｉｎ ｐｈａｓｅ ＩＩａ ｒａｎｄｏｍｉｚｅｄ，ｐｌａｃｅｂｏ－ｃｏｎｔｒｏｌｌｅｄ ｔｒｉａｌ ｉｎ ｓｅｐｔｉｃ ｓｈｏｃｋ ｐａｔｉｅｎｔｓ，Ｃｒｉｔｉｃａｌ Ｃａｒｅ，２０１７，２１（２１３），１－１０
２．Ｒｕｓｓｅｌｌ，Ｊａｍｅｓ Ａ．ｅｔ ａｌ．，Ｖａｓｏｐｒｅｓｓｉｎ ｖｅｒｓｕｓ Ｎｏｒｅｐｉｎｅｐｈｒｉｎｅ Ｉｎｆｕｓｉｏｎ ｉｎ Ｐａｔｉｅｎｔｓ ｗｉｔｈ Ｓｅｐｔｉｃ Ｓｈｏｃｋ，Ｎ Ｅｎｇｌ Ｊ Ｍｅｄ，２００８，３５８（９），８７７－８８７．
３．Ｌｅｗｉｓ，Ｒｏｊｅｒ Ｊ．，Ｒａｔｉｏｎａｌｅ ａｎｄ Ｄｅｓｉｇｎ ｏｆ ａｎ Ａｄａｐｔｉｖｅ Ｐｈａｓｅ ２ｂ／３ Ｃｌｉｎｉｃａｌ Ｔｒｉａｌ ｏｆ Ｓｅｌｅｐｒｅｓｓｉｎ ｆｏｒ Ａｄｕｌｔｓ ｉｎ Ｓｅｐｔｉｃ Ｓｈｏｃｋ，Ａｎｎａｌｓ ＡＴＳ，２０１８，１５（２），２５０－２５７
Next, another preferred embodiment of the present invention will be shown.
1. A composition comprising cerepressin for use in the treatment of sepsis in a patient in need of vasopressor therapy, said composition being administered to said patient within 6 hours of the time said patient requires said vasopressor therapy. A composition comprising cerepressin.
2. 2. The use of cerepressin according to claim 1, wherein said patient has or is identified as having an arterial partial pressure of oxygen to inspired oxygen concentration ratio (PaO2 / FiO2 ) of greater than about 200 prior to treatment. Composition.
3. 3. A composition comprising cerepressin for use according to 1 or 2 above, wherein said patient has or is identified as having a serum lactate concentration of less than about 2 mmol/L prior to treatment.
4. A composition comprising cerepressin for use in treating sepsis in a patient, wherein said patient has a serum lactate concentration of less than 2 mmol/L prior to treatment.
5. 5. Use according to Claim 4, wherein said patient is identified as having a serum lactate concentration of less than about 2mmol/L prior to treatment.
6. A composition comprising cerepressin for use in the treatment of sepsis in a patient, wherein the patient has an arterial partial pressure to inspired oxygen concentration ratio (PaO2 / FiO2 ) of greater than about 260 prior to treatment. Composition.
7. 7. Use according to Claim 6, wherein said patient is identified as having a ratio of arterial partial pressure of oxygen to inspired oxygen concentration (PaO2 / FiO2 ) greater than about 260 prior to treatment.
8. 8. A composition comprising cerepressin for use according to 6 or 7 above, wherein the arterial partial pressure of oxygen to inspired oxygen concentration ratio (PaO2 / FiO2 ) is greater than about 300 prior to treatment.
9. 9. A composition comprising cerepressin for use according to any one of claims 1 to 8, wherein said sepsis is vasopressor dependent sepsis.
10. A composition comprising cerepressin for use according to any one of 1, 2, 6, 7 or 8 above, wherein said sepsis is septic shock.
11. A method of treating sepsis in a patient in need of vasopressor therapy comprising administering to said patient a composition comprising cerepressin within 6 hours of said patient requiring said vasopressor therapy. including, method.
12. 12. The method of Claim 11, wherein said patient has or is identified as having a serum lactate concentration of less than about 2 mmol/L prior to treatment.
13. 13. Any one of claims 11 or 12, wherein the patient has or is identified as having an arterial partial pressure of oxygen to inspired oxygen concentration ratio (PaO2 / FiO2 ) of greater than about 200 prior to treatment. Method.
14. A method of treating sepsis comprising administering a composition comprising cerepressin to a patient in need thereof, wherein said patient has a serum lactate concentration of less than 2 mmol/L prior to treatment.
15. 15. The method of Claim 14, wherein said patient is identified as having a serum lactate concentration of less than about 2 mmol/L prior to treatment.
16. A method of treating sepsis comprising administering a composition comprising cerepressin to a patient in need thereof, wherein said patient has a ratio of arterial partial pressure of oxygen to inspired oxygen concentration of greater than about 260 prior to treatment. (PaO2 / FiO2 ) .
17. 17. The method of Claim 16, wherein said patient is identified as having a ratio of arterial partial pressure of oxygen to inspired oxygen concentration (PaO2 / FiO2 ) greater than about 260 prior to treatment.
18. 18. The method of claim 16 or 17, wherein the ratio of arterial partial pressure of oxygen to inspired oxygen concentration (PaO2 / FiO2 ) is greater than about 300 prior to treatment.
19. 19. The method of any one of 11 to 18 above, wherein said sepsis is vasopressor dependent sepsis.
20. 19. The method of any one of 11, 13, 16, 17 or 18 above, wherein said sepsis is septic shock.
21. 21. A composition comprising cerepressin for use or method according to any one of claims 11 to 20, wherein said cerepressin is administered intravenously or subcutaneously.
22. 21. Use or method according to any one of claims 11 to 20, wherein said cerepressin is administered by continuous intravenous infusion at a dose rate of about 1.7 ng/kg/min to about 7.5 ng/kg/min. A composition comprising cerepressin for
23. said cerepressin has an intravenous infusion initiation rate of from about 1.7 ng/kg/min to about 5.0 ng/kg/min; 23. A composition comprising cerepressin for use or method according to 22 above, administered by continuous intravenous infusion at kg/min.
24. 21. A composition comprising cerepressin for use or method according to any one of claims 11 to 20, wherein said cerepressin is administered with an additional antihypotensive agent.
25. 21. A composition comprising cerepressin for use or method according to any one of claims 11 to 20, wherein said cerepressin is administered with a cardiotonic agent.
References 1. Russell, James A.; et al. , V1A agonist is an effective substrate for norepinephrine in phase IIa randomized, placebo-controlled trial in septic shock patients, Critical Care, 2017, 21-2103
2. Russell, James A.; et al. , Vasopressin versus Norepinephrine Infusion in Patients with Septic Shock, N Engl J Med, 2008, 358(9), 877-887.
3. Lewis, RojerJ. , Rationale and Design of an Adaptive Phase 2b/3 Clinical Trial of Selepressin for Adults in Septic Shock, Annals ATS, 2018, 15(2), 250-257
Claims (14)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201862767889P | 2018-11-15 | 2018-11-15 | |
| US62/767,889 | 2018-11-15 | ||
| PCT/IB2019/059788 WO2020100080A1 (en) | 2018-11-15 | 2019-11-14 | Compounds, compositions and methods for treating sepsis |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2022507380A JP2022507380A (en) | 2022-01-18 |
| JPWO2020100080A5 true JPWO2020100080A5 (en) | 2022-11-21 |
Family
ID=68655588
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2021526255A Pending JP2022507380A (en) | 2018-11-15 | 2019-11-14 | Compounds, Compositions and Methods for Treating Sepsis |
Country Status (10)
| Country | Link |
|---|---|
| US (1) | US20220008499A1 (en) |
| EP (1) | EP3880226A1 (en) |
| JP (1) | JP2022507380A (en) |
| KR (1) | KR20210093925A (en) |
| CN (1) | CN113164550A (en) |
| AU (1) | AU2019381328A1 (en) |
| BR (1) | BR112021009392A8 (en) |
| CA (1) | CA3119792A1 (en) |
| MX (1) | MX2021005693A (en) |
| WO (1) | WO2020100080A1 (en) |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SE0001865D0 (en) * | 2000-05-19 | 2000-05-19 | Astrazeneca Ab | Management of septic shock |
| JO2937B1 (en) | 2004-08-11 | 2016-03-15 | فيرينغ.بي.في | Peptidic Vasopressin Receptor Agonists |
| PL1984012T3 (en) * | 2006-02-13 | 2016-07-29 | Ferring Bv | Use of peptidic vasopressin receptor agonists |
| WO2009009907A1 (en) * | 2007-07-18 | 2009-01-22 | The University Of British Columbia | Use of vasopressin-receptor agonists for the treatment of septic shock |
| FR2959414B1 (en) * | 2010-04-30 | 2016-01-08 | Luc Quintin | COMBINATION OF MOLECULES FOR THE TREATMENT OF HYPOTENSION DURING SEPTIC, CARDIOGENIC, OR ANAPHYLACTIC REFRACTORY OR TERMINAL HEMORRHAGIC SHOCK, AFTER CORRECTION OF VOLEMIE AND STATE OF REFRACTORY MAL ASTHMATIC |
| JP6259905B2 (en) * | 2013-03-20 | 2018-01-10 | シュピーンゴテック ゲゼルシャフト ミット ベシュレンクテル ハフツング | Adrenomedullin to guide hypotension treatment |
-
2019
- 2019-11-14 EP EP19809167.0A patent/EP3880226A1/en active Pending
- 2019-11-14 US US17/294,169 patent/US20220008499A1/en not_active Abandoned
- 2019-11-14 WO PCT/IB2019/059788 patent/WO2020100080A1/en active Application Filing
- 2019-11-14 AU AU2019381328A patent/AU2019381328A1/en active Pending
- 2019-11-14 CN CN201980075375.5A patent/CN113164550A/en active Pending
- 2019-11-14 CA CA3119792A patent/CA3119792A1/en active Pending
- 2019-11-14 JP JP2021526255A patent/JP2022507380A/en active Pending
- 2019-11-14 MX MX2021005693A patent/MX2021005693A/en unknown
- 2019-11-14 KR KR1020217016390A patent/KR20210093925A/en active Search and Examination
- 2019-11-14 BR BR112021009392A patent/BR112021009392A8/en unknown
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